FDA UDI
In Commercial Distribution
🇺🇸 United States
AURORA® Surgiscope®
DI: 00850002332247
·
Model: ASX15/80
·
Integra Lifesciences Corporation
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- AURORA® Surgiscope®
- Primary DI
- 00850002332247
- Version / Model
- ASX15/80
- Catalog Number
- ASX15/80
- Company Name
- Integra Lifesciences Corporation
- Labeler DUNS
- 083171244
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-05-18
- Public Version
- 7
- Public Version Date
- 2023-11-03
- Public Version Status
- Update
- Public Device Record Key
- 4205c390-8c7f-4960-95b3-7826d7ec1ff0
Device Description
AURORA® Surgiscope® System
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GZT | Retractor, Self-Retaining, For Neurosurgery | Neurology | 882.4800 | 2 |
| GWG | Endoscope, Neurological | Neurology | 882.1480 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45045 | Rigid optical intracranial/spinal endoscope, single-use | An endoscope with a rigid distal portion intended for the visual examination and treatment of the brain (e.g., ventricles, hydrocephalus) and/or spine and contents [e.g., vertebrae, intervertebral discs, spinal cord (myeloscopy)]; it is not dedicated for use in the epidural space (i.e., not a dedicated epiduroscope). Anatomical images are transmitted to the user by the device through relayed lens optics or a fibreoptic bundle; it does not include video imaging capability, however, might be used with a separate video camera for optional video image viewing. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850002332247 | GS1 |
Customer Contacts
- Phone
- +1(800)654-2873
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K201840 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 80 | Millimeter |